📖 About this Domain
This domain addresses the operational and regulatory aspects of subject recruitment, the informed consent process, and enrollment. It focuses on the compliant execution of protocol-specified procedures for identifying and entering subjects into a clinical trial.
🎓 What You Will Learn
- You will learn to implement IRB/IEC-approved recruitment and retention strategies in compliance with regulations.
- You will learn the required elements of informed consent as defined by 21 CFR 50 and ICH E6, including for vulnerable populations.
- You will learn to apply protocol-specific inclusion and exclusion criteria to screen and confirm subject eligibility.
- You will learn the mechanics of subject enrollment, including randomization, blinding, and maintenance of enrollment logs.
🛠️ Skills You Will Build
- You will build skills to critically evaluate recruitment materials to prevent coercion or undue influence.
- You will build skills in conducting and documenting the informed consent process to ensure subject understanding.
- You will build skills in performing meticulous source document verification to confirm all eligibility criteria are met.
- You will build skills in managing the logistical procedures for randomization and study drug assignment.
💡 Top Tips to Prepare
- Memorize the key regulations for informed consent, including 21 CFR 50, 45 CFR 46, and ICH E6(R2) Section 4.8.
- Focus on the distinct consent requirements for vulnerable subjects, including the roles of a Legally Authorized Representative (LAR) and assent.
- Understand the critical timeline of screening procedures relative to obtaining informed consent to avoid protocol deviations.
- Practice applying inclusion/exclusion criteria from sample protocols to hypothetical subject scenarios.
📖 About this Domain
This domain covers key concepts related to 4: Study Management/Conduct of the Study.
🎓 What You Will Learn
- Core concepts of 4: Study Management/Conduct of the Study
- Best practices and implementation
- Real-world application scenarios
🛠️ Skills You Will Build
- Technical proficiency in 4: Study Management/Conduct of the Study
- Problem-solving abilities
- Practical implementation skills
💡 Top Tips to Prepare
- Review official documentation and study guides
- Practice with hands-on exercises
- Focus on understanding core principles
📖 About this Domain
This domain details the composition, function, and operations of the Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB). It focuses on the board's mandate to protect the rights, safety, and welfare of human research subjects. The content is grounded in key regulations such as 21 CFR Part 56 and ICH E6(R2) guidelines.
🎓 What You Will Learn
- You will learn the specific regulatory requirements for IRB/IEC composition, membership, and quorum as mandated by federal regulations.
- You will differentiate between types of IRB review, including full board review, expedited review procedures, and criteria for exemption.
- You will understand the criteria for IRB approval of research, including risk/benefit assessment, equitable subject selection, and informed consent process review.
- You will grasp the IRB's ongoing oversight responsibilities, such as continuing review, protocol amendment review, and management of unanticipated problems.
🛠️ Skills You Will Build
- You will build the skill to prepare and submit complete and compliant initial and continuing review packages to the IRB/IEC.
- You will develop the ability to author and revise informed consent forms (ICFs) that meet all required elements of 21 CFR 50 and ICH E6(R2).
- You will gain proficiency in responding to IRB/IEC queries, stipulations, and requests for modification to secure protocol approval.
- You will master the maintenance of the regulatory binder, ensuring all IRB/IEC correspondence and approvals are documented per GCP.
💡 Top Tips to Prepare
- Concentrate your study on 21 CFR Part 56 (Institutional Review Boards) and 21 CFR Part 50 (Protection of Human Subjects).
- Thoroughly review ICH E6(R2) Section 3, which outlines the specific responsibilities and procedures of the IRB/IEC.
- Memorize the ethical principles of the Belmont Report (respect for persons, beneficence, justice) as they form the basis for IRB decision-making.
- Focus on the nuances of IRB records, continuing review intervals, and the specific criteria for waiving or altering informed consent.
📖 About this Domain
This domain details the regulatory and operational requirements for the control of investigational products and devices. It focuses on accountability, storage, dispensing, and disposition to ensure subject safety and data integrity. Compliance with 21 CFR 312, 21 CFR 812, and ICH GCP is paramount.
🎓 What You Will Learn
- You will learn to maintain precise investigational product accountability records, including receipt, dispensing, and final disposition logs.
- You will learn the specific FDA regulations for investigational drugs under an IND (21 CFR 312) and devices under an IDE (21 CFR 812).
- You will learn to manage the IP strictly per the protocol, including requirements for storage, preparation, and administration.
- You will learn the unique control and tracking requirements for investigational devices to ensure use is limited to authorized personnel.
🛠️ Skills You Will Build
- You will build skills in meticulous documentation of IP accountability to withstand regulatory scrutiny during an audit or inspection.
- You will build the skill to interpret and apply federal regulations (21 CFR) and GCP guidelines to IP management tasks.
- You will build skills in risk mitigation for IP, including preventing temperature excursions, unblinding, and administration errors.
- You will build the skill to adhere to sponsor and institutional SOPs for all aspects of IP handling and control.
💡 Top Tips to Prepare
- Focus study on 21 CFR 312.62 and 21 CFR 812.100, which outline investigator responsibilities for control of the investigational article.
- Memorize the core components of an IP accountability log and be able to trace the product from shipment receipt to subject dispensing and final return.
- Distinguish the key regulatory differences between managing an investigational drug versus an investigational device, especially regarding labeling.
- Thoroughly review ICH E6(R2) Section 4.6, which details the investigator's responsibilities for the investigational product.
📖 About this Domain
This domain addresses the lifecycle of clinical trial data, focusing on data integrity, quality, and security from collection to archival. It covers regulatory standards for Case Report Forms (CRFs), source data, and electronic systems. Mastery ensures data is reliable for analysis and regulatory submission.
🎓 What You Will Learn
- Principles of CRF/eCRF design, data collection methods, and proper correction procedures.
- The process of source data verification (SDV) to ensure data matches source documentation.
- The query management lifecycle, including generation, tracking, and resolution of data discrepancies.
- Regulatory requirements for electronic data capture (EDC) systems under 21 CFR Part 11.
🛠️ Skills You Will Build
- Applying ALCOA-C principles to maintain data quality and integrity during data collection and transcription.
- Navigating EDC systems for efficient data entry, query resolution, and data review.
- Executing meticulous source document review and verification against clinical database entries.
- Communicating effectively with clinical monitors and data managers to resolve data clarification forms (DCFs).
💡 Top Tips to Prepare
- Master the specifics of 21 CFR Part 11 for electronic records and electronic signatures.
- Understand the complete data flow from subject visit to database lock, including all quality control steps.
- Commit key terminology to memory: SDV, CRF, EDC, query, data validation, and database lock.
- Review the SOCRA Certification Exam Detailed Content Outline for specific data management tasks and knowledge areas.
📖 About this Domain
This domain covers the foundational regulatory and ethical framework governing clinical trials. It emphasizes the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulations, such as the U.S. Code of Federal Regulations (CFR). Mastery of this content is essential for ensuring trial integrity and human subject protection.
🎓 What You Will Learn
- You will learn the core principles of ICH E6(R2) and their application to trial conduct, data quality, and subject safety.
- You will learn the specific responsibilities of the Investigator, Sponsor, and Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- You will learn the required elements of the informed consent process as detailed in 21 CFR Part 50 and ICH GCP.
- You will learn the requirements for maintaining essential documents and ensuring proper source documentation practices.
🛠️ Skills You Will Build
- You will build the skill to interpret and apply complex regulatory requirements to operational trial activities.
- You will develop the ability to identify non-compliance and potential regulatory deviations in clinical research scenarios.
- You will build proficiency in navigating the ethical principles of the Belmont Report and their codification in federal regulations.
- You will develop the skill to assess the adequacy of informed consent forms and procedures for regulatory compliance.
💡 Top Tips to Prepare
- Focus on memorizing the distinct responsibilities of the Investigator (ICH Section 4) and Sponsor (ICH Section 5).
- Create a cross-reference chart comparing ICH E6(R2) guidelines with key sections of 21 CFR Parts 50, 56, and 312.
- Thoroughly understand the 13 principles of GCP as they form the basis for many exam questions.
- Practice applying the definitions of key terms like 'adverse event,' 'serious adverse event,' and 'clinical investigation' to case studies.
